SI-BONE, Inc. Announces iFuse MIS SI Joint Fusion Gains Support from North American Spine Society (NASS) with Positive Coverage Policy Recommendation
SAN JOSE, Calif., June 1, 2015 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System®, a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that the North American Spine Society (NASS) has issued their formal coverage recommendation for MIS SI joint fusion titled "Percutaneous Sacroiliac Joint Fusion, Defining Appropriate Coverage Positions." The evidence-based coverage policy, posted on the NASS website today, is based primarily on the 19 SI-BONE iFuse published clinical studies and states "the Coverage Committee recommends coverage for percutaneous SI joint fusion when the criteria [outlined] are met." Based on the available published evidence considered and evaluated, the committee concluded that the SI joint is an established source of chronic low back and buttock pain and that the MIS SI joint fusion procedure itself has proven to be relatively safe. The coverage criteria outlined in the document include a list of eight criteria specifically intended to ensure nonsurgical options have been thoroughly evaluated for at least six months and also to confirm that the SI joint is in fact the primary pain source while ruling out other potential sources of pain within the lumbar spine-hip-SI joint complex through a combination of imaging studies, physical examination tests and an intra-articular SI joint injection. The committee notes that although there is no single clinical, imaging or provocative test that definitely confirms the SI joint as a primary pain source, a critical step in confirming the SI joint as the source of pain involves a diagnostic intra-articular injection of the SI joint with local anesthetic.
The committee summarized that available evidence shows pain score outcomes appear to be consistent and improve with both open and MIS SI joint fusion procedures but MIS procedures seem to be associated with less blood loss and fewer complications compared to open procedures. Given that open procedures have been previously covered, it therefore seems reasonable to extend coverage to percutaneous or minimally invasive SI joint fusion procedures.
Jeffrey Dunn, President and CEO of SI-BONE commented on the NASS recommendation: "NASS is the premier multidisciplinary medical organization dedicated to improving spine care as well as the largest spine society in the world and their acknowledgment of the SI joint as an established source of chronic low back pain and their recommendation for MIS SI joint fusion as a treatment option for those patients who satisfy the diagnostic criteria is a major milestone in the treatment of SI joint disorders. The NASS policy recommendation further validates the existing coverage recommendation from ISASS (International Society for the Advancement of Spine Surgery) and should help to further expand coverage for the iFuse procedure throughout the US."
Clinical publications have identified the SI joint as a pain generator in 15% to 30% of low back pain patients.1-4 In addition, the prevalence of SI joint pain in post-lumbar fusion, so called "failed back surgery" patients, has been shown to be up to 43%.5 Of these patients, some may have degenerative sacroiliitis or SI joint disruptions. Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical management of the SI joint fails, surgical options such as the iFuse procedure may be considered.
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse System is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders. The company has developed, and is manufacturing and marketing, minimally invasive products for patients with certain SI joint disorders. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2015 SI-BONE, Inc. All Rights Reserved. 9201.060115
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2 Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3 Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
4 Sembrano JNa, Polly DW.a How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5 DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Medicine. 2011;12:732-9.
a Investigators in a clinical research study sponsored by SI-BONE, but they have no financial interest in the company.